BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 6146133 · Received December 5, 2016

    Report

    Report Number
    3005985723-2016-00416
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    November 30, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K141989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REPORTED EVENT: THE EVENT REPORTED THAT A TIBIAL CHECKPOINT WAS NOT REMOVED FROM THE PATIENT'S GREATER TROCHANTER PRIOR TO CLOSURE OF INCISION. DEVICE EVALUATION AND RESULTS: THE DEVICE WAS LEFT IMPLANTED IN THE PATIENT SO INSPECTION WAS NOT PERFORMED. DEVICE HISTORY REVIEW: REVIEW OF INSPECTION RECORDS SHOW THAT 2079 PARTS WERE ACCEPTED ON 04/21/2016 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS FOR P/N 111651 SHOW ONE (1) OTHER COMPLAINT RELATED TO THE FAILURE. THE PR# IS (B)(4). CONCLUSIONS: THE USER DID NOT PERFORM THE INTRAOPERATIVE STEP OF REMOVING THE TIBIAL CHECKPOINT PRIOR TO INCISION CLOSURE. THE DEVICE HAS NO DEFICIENCY. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY PROCEDURE WAS PERFORMED ON A PATIENT USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE POST OP X-RAYS REVEALED THAT THE TIBIAL CHECKPOINT WAS LEFT IN THE GREATER TROCHANTER OF THE PATIENT.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY PROCEDURE WAS PERFORMED ON A PATIENT USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). THE POST OP X-RAYS REVEALED THAT THE TIBIAL CHECKPOINT WAS LEFT IN THE GREATER TROCHANTER OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796290 TIBIAL, CHECKPOINT, STERILE STEREOTACTIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W45087-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other